An interventional study of Physical activity in Overweight and Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-02.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science
The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.
Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 188 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Behavioral: Physical activity
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Behavioral: Physical activity
Bicycling to/from work/school/university. No requirements for exercise intensity; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week; Avg distance per day Females 9-15 km; Males 11-17 km
Behavioral: Physical activity
Receives no intervention.
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Time frame: Change from baseline in peripheral insulin sensitivity at 3 months
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Time frame: Change from baseline in peripheral insulin sensitivity at 6 months
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time frame: Change from baseline in endogenous thrombin potential at 3 months
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time frame: Change from baseline in endogenous thrombin potential at 6 months
Glycaemic control
Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
Time frame: Baseline, 3 and 6 months
Central insulin sensitivity
Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Time frame: Baseline, 3 and 6 months
Maximal oxygen uptake (ml/O2/kg/min)
Measured using indirect calorimetry and an incremental bicycle protocol
Time frame: Baseline, 3 and 6 months
Abdominal fat mass
Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Time frame: Baseline, 3 and 6 months
Metabolic syndrome
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Time frame: Baseline, 3 and 6 months
Haemostatic balance II
1: Coagulation: Fibrinogen, Tissue factor(TF), prothrombin fragment 1+2. 2: Fibrinolysis: Tissue type plasminogen activator(tPA:AG), Plasminogen activator inhibitor type 1(PAI-1:AG). 3: Endothelial cell function: von Willebrand factor(vWF), Tissue factor pathway inhibitor (TFPI). 4: Inflammation: C-Reactive protein.
Time frame: Baseline, 3 and 6 months
Health related quality of life and other psycho-social outcomes
Measured using questionaries (SF-36), semi-structured interviews and observations
Time frame: Baseline, 3 and 6 months
Anthropometry
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Time frame: Baseline, 3 and 6 months
Sleep habits
Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Time frame: Baseline, 3 and 6 months
Skeletal muscle biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time frame: Baseline, 3 and 6 months
Subcutaneous adipose tissue biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time frame: Baseline, 3 and 6 months
Exercise compliance
Adherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention
Time frame: Baseline, 3 and 6 month
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Copenhagen